# BME100 f2017:Group5 W1030 L2

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# OUR TEAM

 Name: Thomas On Name: Katerina Liong Name: Sarah Nystrom Name: Aditya Mishra Name: Ameil Jones

# LAB 2 WRITE-UP

## Device Image and Description

This product is a temporary tattoo that utilizes special ink which changes color based on amount of uv exposure. By using this product, a customer would be reminded to reapply sunscreen in the time it takes for the sunscreen to wear off. Since the purpose of sunscreen is to block a certain amount of UV rays, applying sunscreen over the applied tattoo would allow the tattoo to effectively "sense" when the sunscreen is no longer effective, as it is UV-sensitive. As more of the sunscreen wears off, UV rays will easily hit the pigments in the tattoo causing it to change colors.

This is a proposal of the main design of our product. It would serve as the logo of our company. We chose the sun as the tattoo since our product is related to the sun. The sun is the tattoo that is applied to your body while the square in our picture represents the backing paper and transfer film. Our company will sell many types of tattoos to attract different age groups, but for our "main" tattoo we wanted a simple design so that it doesn't appear to be only for children.

## Technical and Clinical Feasibility

Technical Feasibility
a. What are the technologies needed?
We would need photochromic ink, which is sensitive to UV radiation in such a way that it changes colors based on the amount of exposure; and a way to scan images to add the different designs to the temporary tattoo. We would use this ink instead of the normal ink used in decal tattoos. We would need the backing paper, silicone release coating, and transfer film (https://temporarytattoos.com/blog/how-do-temporary-tattoos-work/). There would also need to be an adhesive on for the tattoo to stick to your skin.

b. What are the challenges?
The challenges with our design are finding which chemical to use that will measure UV exposure, that will also be safe to apply to human skin. Another challenge will be finding out a way for the tattoo to noticeably change color after a certain amount of UV exposure. Another challenge will be to decide whether our tattoo should be able to change colors only once or if sunscreen is reapplied will it fade back to the original color.

c. What are some potential obstacles?
Possible issues that could come up with this product are: - the tattoo wearing off/not lasting long enough to complete its job through exposure to water or friction - the photochromic ink could simply not work, by either not changing colors or not doing so on time, which would defeat the purpose of the product

In the fundability worksheet, this product would receive a score of 3 in the technical feasibility category, as most of the technologies exist currently--the only developmental work that would need to be done is slight alteration of existing photochromic ink to make it specifically sensitive to measured amounts of UV-rays.

Clinical Feasibility
a. Given the technical feasibility will it work in the clinical trials?
The tattoo will work in clinical trials. The technical feasibility is a 3 since it is easy to produce which means the clinical feasibility only depends on the effectiveness of the product. Our product should have no problem fixing the issue of reapplying sunscreen and only needs to be tested to see if its safe for human skin.

b. What are the clinical risks?
The possible risks in clinical trials would be: - the special photochromic ink possibly being an irritant, and/or causing allergic reactions with the customers' skins. - the product being rendered ineffective by patients who forget to look at or don't notice the color change of their tattoo.

c. Have similar products been in clinical trial? How long was the trial?
Yes a similar product has been used by L'Oreal. The trial was between 6 months and a year since the product was in trial in 2015 and was released in early January 2016. (http://www.loreal.com/media/press-releases/2016/jan/loreal-debuts-first-ever-stretchable-electronic-uv-monitor)

In the fundability worksheet, this product would receive a score of 2 in the clinical feasibility category, as most of the technologies were already tested; however, the modification of the altered UV-sensitive photochromic ink would have to be tested and FDA approved, as it is still a possibility for leading to health risks, being an unknown chemical for human skin.

## Market Analysis

Value Creation
The prototype provides the customer with an easy way to monitor skin exposure to UV rays which provides value to customers interested in reducing UV damage. This prototype is less expensive than most other products that are able to do this, and also lasts longer than many similar products that tend to wear off over time. The way sun exposure is measured with this product is different than competing brands and offers a more versatile alternative to using an bracelet or a sticker. There are also not many other companies that sell products similar to this, so creating this prototype would make staying safe in the sun more readily available to the consumer.

Our product is also unique and more valuable because of the interesting and cool designs--thus, it serves an aesthetic purpose of looking "cool" instead of solely the functional one.

Manufacturing Cost
The cost to create our design will be about 5 cents per tattoo. This is based on the cost of paper (7.8 cents per square inch of backing paper), ink (5 cents per square inch of ink), and the plastic cover (about 0.2 cents per square inch). Each tattoo will be 1 inch by 1 inch in size, therefore the estimated cost to create one tattoo will be about 5-6 cents. (June Tailor Inkjet Printable Temporary Tattoo Sheet, 8.5 by 11-Inch: https://www.amazon.com/June-Tailor-JT-481-Printable-Temporary/dp/B00KHFJ89C).

Sales Price
The anticipated average sale price (ASP) will about 25 cents per tattoo (5 times the estimated cost per tattoo), and about 30 will be sold per pack, so each pack will be $7.50. Market Size The market size will be about$112,470,898 per year. This was calculated knowing that about 69% of Americans use sunscreen (http://abcnews.go.com/Health/SkinCare/story?id=7637104&page=1), and since the U.S. population is 326,002,603, this means about 224,941,796 Americans would be using the product. This number multiplied by 0.05 and $7.50 which calculates the market size ($84,353,173.50 per year). 69% of Americans use sunscreen (http://abcnews.go.com/Health/SkinCare/story?id=7637104&page=1), and since the U.S. population is 326,002,603, this means about 224,941,796 Americans could be interested in our product. Since our packs are sold in sizes of 30, it lets people apply one tattoo a day; since people tend to wear sunscreen around summertime (and not for most of the year, despite the UV rays year-round), they would likely wear sunscreen (and thus this product) during 4/12 months, needing 4 packs a year. In order to calculate our market size, $84,353,173.50 would be multiplied by 4 to get a final market size of$337,412,694 / year. This puts our market size in the range of 2 under the Fundability Worksheet.

## Fundability Discussion

With the 1's in place in Customer Validation, Regulatory Pathway, and Reimbursement (as placeholders, as we cannot find these at this time), our product should not be funded, having received a score of only 24.

However, based on our positive IP Position, relative lack of Competition, potential Clinical Feasibility, potential market size, and high Technical Feasibility, we predict that this product has great market potential, especially if we get a chance to research the Customer Validation more and get started on FDA approval (which would affect the scores of Regulatory Pathway and Reimbursement--though potentially reimbursement would be a 1 since it's cheap enough and considered "preventative," not vital). For these reasons, we believe that the score would be high enough to be a good score investment-wise. We would predict our Customer validation to be a 3 (as those already using sunscreen would likely be invested in reapplication) and 2 for Regulatory Pathway, given our IP Position research which revealed that although our product is unique, it is similar to others and uses mostly technology that has already been approved.

Group 5 10:30 Fundability Worksheet for UV-based Temporary Tattoo Sunscreen-Reapplication-Reminder